A Prognostic Model for Drug-induced Liver Injury in China

NCT05060289 | Recruiting

• 1 other identifier: 2021-P2-290-01
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 13

Brief Summary

A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers. A prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .

Conditions

Drug-induced Liver Injury

Keywords

prognostic model(s); biomarker(s); endpoint event(s)

Outcome Measures

Primary Outcomes (2)

• death/liver transplantation

  DILI has a primary, contributory role for the death (liver-related mortality) or no role for the death (all-cause mortality) . DILI is the primary indication for liver transplantation.

  1 year

• acute liver failure

  Acute liver failure is defined as elevated bilirubin and prolonged international normalized ratio (INR) ≥1.5 accompanied by mental disturbance within 26 weeks after DILI onset without underlying chronic liver diseases.

  1 year

Secondary Outcomes (2)

• chronic DILI

  2 years

• recovery

  2 years

Study Arms (2)

Modeling group

The data of modeling group is used to construct a predictive model of DILI endpoint events.

Validation group

Validation group is used to validate the predictive model externally.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult with drug-induced liver injury

You may qualify if:

• RUCAM ≥6 and met one of the following biochemical conditions: (1) ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN.
• RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis.
• Onset to enrollment ≤3 months.

You may not qualify if:

• Hepatotropic viral infection: hepatitis A, B, C, D and E.
• Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
• Hypoxic ischemic hepatitis and congestive liver disease.
• Alcohol consumption: male \>40g/d, female \>20g/d, and ≥5 years.
• Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
• Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.
• Parasitic infection.
• Sepsis.
• Previous liver transplantation or bone marrow transplantation.
• Pregnancy or lactation.
• Genetic and metabolic liver diseases.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (13)

Beijing 302 Hospital

Beijing, Beijing Municipality, 100166, China

RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, 100050, China

RECRUITING

Beijing You 'an Hospital, Capital Medical University

Beijing, 100069, China

RECRUITING

Beijing Ditan Hospital

Beijing, 100102, China

ACTIVE NOT RECRUITING

Peking University Third Hospital

Beijing, 100191, China

ACTIVE NOT RECRUITING

The Second Affiliated Hospital of Dalian Medical University

Dalian, 116023, China

RECRUITING

Qinzhou First People's Hospital

Guangxi, 535009, China

ACTIVE NOT RECRUITING

Hebei CNPC Central Hospital

Hebei, 050011, China

ACTIVE NOT RECRUITING

Jiaozuo People's Hospital

Jiaozuo, 454002, China

RECRUITING

The Second Hospital of Lanzhou University

Lanzhou, 730046, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, 266003, China

RECRUITING

Qinghai People's Hospital

Qinghai, 810007, China

RECRUITING

Yuncheng Central Hospital

Yuncheng, 044099, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, liver histopathology (if any)

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Officials

• Xinyan Zhao

  Beijing Friendship Hospital

  STUDY CHAIR

• Zhengsheng Zou

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

• Yu Chen

  Beijing You 'an Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

• Juan Li

  Qinghai People's Hospital

  PRINCIPAL INVESTIGATOR

• Pingying Li

  Qinghai People's Hospital

  PRINCIPAL INVESTIGATOR

• Xiaoju Liu

  Qinzhou First People's Hospital

  PRINCIPAL INVESTIGATOR

• Liang Wang

  Lanzhou University Second Hospital

  PRINCIPAL INVESTIGATOR

• Juan Luo

  Hebei CNPC Central Hospital

  PRINCIPAL INVESTIGATOR

• Huahua Wang

  Jiaozuo People's Hospital

  PRINCIPAL INVESTIGATOR

• Hui Wang

  Jiaozuo People's Hospital

  PRINCIPAL INVESTIGATOR

• Jikang Yang

  Jiaozuo People's Hospital

  PRINCIPAL INVESTIGATOR

• Doudou Hu

  Qingdao Municipal Hospital

  PRINCIPAL INVESTIGATOR

• Qiuju Tian

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

• Rongkuan Li

  The Second Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

• Lu Li

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Liuyi Chang

  Yuncheng Central Hospital

  PRINCIPAL INVESTIGATOR

• Lu Zhang

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

• Yuanjiao Gao

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Wang

CONTACT

18810530724; wangyanpku@163.com

Zikun Ma

CONTACT

18311270304; maazikun0114@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 29, 2021
• Study Start: May 25, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)